Alzheimer’s imaging pact
This article was originally published in The Gray Sheet
Executive Summary
Drug-diagnostic giant Bayer Schering licenses an Alzheimer's-detecting positron emission tomography agent from Philadelphia molecular imaging firm Avid Radiopharmaceuticals. The deal, announced June 19, results from a 2005 option agreement between the two companies for AV1/ZK and related fluorine-based compounds, which target amyloid plaques in the brain...
You may also be interested in...
The Alzheimer's Divide
Issues of clinical trial design are at the forefront in Alzheimer's drug development. Researchers and investors are weighing the impact of late-stage failures, even as significant unknowns remain about disease mechanism and the correlation of biochemical markers and clinical effects. A fundamental question hangs over AD drug development, which is unique in many respects: in deciding how to move from Phase II into Phase III, what can you know and how can you know it?
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.